Cleared Traditional

K780224 - MICROCELL COUNTER MODEL CC-108

K780224 is an FDA 510(k) clearance for MICROCELL COUNTER MODEL CC-108, manufactured by Toa Medical Electronics USA, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K780224 · Toa Medical Electronics USA, Inc. · Hematology device
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May 1978
Decision
105d
Days
Class 2
Risk

K780224 is an FDA 510(k) clearance for the MICROCELL COUNTER MODEL CC-108. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toa Medical Electronics USA, Inc. devices

FDA 510(k) Submission Details - K780224

510(k) Number K780224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1978
Decision Date May 19, 1978
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K780224.
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · Toa Medical Electronics USA, Inc. · Jun 1978
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · Coulter Electronics, Inc. · Nov 1977
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · Technicon Instruments Corp. · Nov 1977
DETECTOTERGE AZIDE FREE
K771790 · J.T. Baker Chemical Co. · Oct 1977